Much attention has been paid, in both the medical literature and lay press, to the general issue of healthcare-related infection. The alarming increase in multi-drug resistant organisms, combined with the well-documented costs of treating healthcare-associated infections, has led to a strong worldwide mandate to address and eliminate all potential avenues for infection. Driving these efforts further is the decision by the United States Centers for Medicare and Medicaid Services to no longer reimburse hospitals for costs that can be related to healthcare-acquired infection. Prominent among the listed adverse events that will no longer be covered are all catheter-related infections. Arising from the consequent strong drive by hospitals and the health care system to eliminate catheter-related infection, multiple new procedures and products have been introduced. These have included antibiotic-impregnated dressings and catheters, antibiotic-impregnated dressing adjuncts, catheter access point cleansing devices, and the application of new rigorous catheter care guidelines. Despite these efforts, catheter-related infections continue.
All existing vascular catheter dressings rely on a simple Band-Aid® type covering mechanism that presses the catheter flat against the skin. Two types of such dressings are currently recommended by the United States Centers for Disease Control and Prevention: one consisting of gauze and tape, and the second consisting of a self-adhesive film. While the dressing material itself may be sterile at first, its inability to seal at the catheter-dressing exit point precludes maintenance of this sterility. The result is the need to change the catheter dressing to a new clean dressing at frequent intervals. The catheters themselves must also be removed at specified intervals, and new catheters placed. Additionally, any movement of the catheter loosens the dressing, compounding sterility issues. Water and contaminating fluids have direct access to the catheter and its insertion site. Catheter movement and non-sterility can lead to other complications such as thrombophlebitis as well.
In addition to the adverse sequelae of infection and thrombophlebitis—as well as caregiver inefficiency and patient discomfort resulting from catheter and dressing changes—other problems continue to plague current catheter and catheter care systems. First, compounding the fundamental problem of inadequate dressing structure, is the tremendous variability in the methodology for placing traditional catheters and catheter dressings. Catheter placement and care techniques are very user-dependent, both from an institutional and individual caregiver standpoint. Clinically, this leads to an unacceptably high incidence of sub-optimally placed intravascular catheters and intravascular catheter dressings—catheters and dressings that are already fundamentally inadequate by design. Second, adequate sterile securement of vascular catheters continues to be an issue. The two traditional patch type dressings recommended by the CDC only partially secure the catheter, relying on supplemental non-sterile supportive tape or other specifically-applied securement devices that serve to compound the problem of insufficient sterility. Inadvertent pulling out of vascular catheters by patients is not uncommon, and can lead to significant blood loss, unsafe loss of vascular access, and even death.
The fact that new dressing adjuncts have been so quickly-adopted demonstrates both the understanding by the medical-industrial system of the inadequacy of traditional intravascular catheters and dressings, and the thirst by this system for a solution to the problem of catheter-related infection. In the final analysis, however, these compensatory measures are just that—technical and pharmacologic maneuvers that simply compensate for an antiquated and suboptimal approach to vascular catheter placement and care. Clearly, a need exists for improved catheter placement and catheter dressing equipment and techniques.